FDA Recruits Payers to Submit Quality Feedback on Medical Devices

The federal agency has called on several large commercial payers to evaluate the quality and safety of FDA-approved medical devices for manufacturers.

September 12, 2018 - FDA has launched a new quality assurance program that leverages feedback from commercial payers about medical device coverage requirements in order to expedite approvals.

The Private Payor Program (PPP) is a voluntary program for medical device manufacturers to receive feedback from FDA, payers, and private technology assessors. Manufacturers in the PPP use the feedback from critiquing organizations to speed up approval processes. The faster approval process then allows payers to add new medical devices onto formularies at faster rates.

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In addition, FDA also updated medical device communications between payers, formulary committees, and other stakeholders. The changes implemented by the federal agency are designed to facilitate the exchange of important economic and patient safety information between stakeholders and device manufacturers.

“As I said at the outset, our policies serve a twin purpose,” said FDA Commissioner Scott Gottlieb. “We’re focused on ensuring efficient, timely access to new technologies; but also to make sure that the same policies that promote these goals also make our regulatory programs more rigorous, more science-based, and more effective. Promoting product safety is a touchstone for all of our new policy efforts.”

In an accompanying blog post, Gottlieb provided more details about the PPP and explained the rationale behind bringing commercial payers into the medical device approval process.

FDA noticed gaps in medical coverage during 2011 when medical device approval processes were consistently delayed. A critical pain point for payers was the inability of health plans to provide adequate coverage pending approval. FDA addressed these issues through the Parallel Review Program, a program that allows CMS and FDA to evaluate clinical evidence before a device receives approval.

Gottlieb explained that the Parallel Review Program successfully expedited the review of safe medical devices for patients. The results of the Parallel Review Program encouraged FDA to develop a similar program for the private sector.

The federal agency contends that the PPP can work to effectively address the challenges of medical device approval in the commercial space, which creates patient safety risks and market disruption.

“The process of acquiring clearance or approval from the FDA, and then coverage from a payer, can take several years to achieve,” Gottlieb explained.

“This delay can be challenging for patients, particularly those with limited alternatives for diagnosing and treating potentially serious medical conditions. In some cases, the long timeframe between those decisions may also have an adverse consequence on smaller medical device companies, which may be unable to sustain themselves for an extended duration of time with limited revenue streams.”

Early participation rates in the PPP are encouraging, Gottlieb concluded. The program helped initiate ten engagements between commercial payers and manufacturers in its first stages. FDA argues that the program is mutually beneficial to payers, manufacturers, and FDA in maximizing the value of medical devices for beneficiaries.

“For manufacturers, it’s early engagement of payers in discussions about evidentiary needs, being able to consider and address coverage-related issues earlier in the process, and gaining the potential for earlier reimbursement through earlier engagement with payors,” Gottlieb said. “For the FDA, it’s improving public health by facilitating more efficient patient access to innovative, safe and effective medical devices.”

“As our work continues to grow in scope and complexity, so must our efforts to collaborate on innovative and streamlined approaches to finding the best ways to serve the American public.”